Search Images Maps Play YouTube News Gmail Drive More »
Sign in
Screen reader users: click this link for accessible mode. Accessible mode has the same essential features but works better with your reader.

Patents

  1. Advanced Patent Search
Publication numberUS20070179604 A1
Publication typeApplication
Application numberUS 11/668,459
Publication dateAug 2, 2007
Filing dateJan 29, 2007
Priority dateJan 27, 2006
Also published asUS7967857
Publication number11668459, 668459, US 2007/0179604 A1, US 2007/179604 A1, US 20070179604 A1, US 20070179604A1, US 2007179604 A1, US 2007179604A1, US-A1-20070179604, US-A1-2007179604, US2007/0179604A1, US2007/179604A1, US20070179604 A1, US20070179604A1, US2007179604 A1, US2007179604A1
InventorsErnest Lane
Original AssigneeErnest Lane
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Gasket with spring collar for prosthetic heart valves and methods for making and using them
US 20070179604 A1
Abstract
A heart valve prostheses includes an annular member implantable within a biological annulus, a collar extending upwardly from the annular member, and a sewing ring extending from the annular member. A spring structure couples the collar to the annular member and biases the collar to align with the annular member at a predetermined distance above the annular member. During use, the prosthesis is introduced into a biological annulus, and fasteners are directed through the sewing ring into surrounding tissue to secure the prosthesis with the annular member within the biological annulus. A mechanical or bioprosthetic valve is introduced and coupled to the collar, e.g., using tabs or other connectors on the collar. The spring structure allows the collar to be directed towards the annular member and/or folded inwardly, e.g., to facilitate accessing the sewing ring to deliver fasteners.
Images(7)
Previous page
Next page
Claims(30)
1. A prosthesis for receiving a prosthetic valve to replace a preexisting natural or prosthetic heart valve within a biological annulus adjacent a sinus cavity, comprising:
an annular member implantable within a biological annulus for dilating tissue surrounding the biological annulus;
a collar disposed above the annular member, the collar comprising one or more connectors for securing a prosthetic valve to the collar, and
a spring structure coupling the collar to the annular member such that collar is movable relative to the annular member.
2. The prosthesis of claim 1, the collar comprising an annular band coupled to the spring structure.
3. The prosthesis of claim 1, the annular band comprising the one or more connectors for securing a prosthetic valve to the collar.
4. The prosthesis of claim 1, the one or more connectors comprising a plurality of detents extending at partially inwardly from the collar for capturing a portion of a prosthetic valve thereunder.
5. The prosthesis of claim 1, the spring structure comprising a helical member including a first end coupled to the collar and a second end coupled to the annular member.
6. The prosthesis of claim 1, further comprising a sewing ring extending radially outwardly relative to the annular member.
7. The prosthesis of claim 6, the sewing ring comprising a multi-lobular shape.
8. The prosthesis of claim 6, the sewing ring comprising a stiffening structure to maintain perfusion of the coronary arteries.
9. The prosthesis of claim 6, further comprising fabric covering at least a portion of one or more of the annular member, the sewing ring, and the collar.
10. The prosthesis of claim 6, the spring structure being deflectable radially inwardly to at least partially expose the sewing ring to facilitate delivering one or more fasteners into the sewing ring.
11. The prosthesis of claim 1, the collar being biased by the spring structure away from the annular member.
12. The prosthesis of claim 1, the collar being movable along a longitudinal axis towards the annular member.
13. A heart valve assembly, comprising:
an annular prosthesis implantable within a biological annulus, the annular prosthesis comprising an annular member for delivery into the biological annulus, a sewing ring extending radially outwardly from the annular member, and a collar disposed above the annular member and coupled to the annular member by a spring structure; and
a prosthetic valve comprising a frame securable to the collar.
14. The heart valve assembly of claim 13, the collar comprising an annular band coupled to the spring structure.
15. The heart valve assembly of claim 13, the collar including one or more connectors for securing the prosthetic valve to the annular prosthesis.
16. The heart valve assembly of claim 14, the one or more connectors comprising a plurality of detents extending at partially inwardly from the collar for capturing a portion of the prosthetic valve thereunder.
17. The heart valve assembly of claim 13, wherein the frame comprises one or more ears extending downwardly, and the collar comprises one or more grooves for receiving the one or more ears.
18. The heart valve assembly of claim 13, wherein the prosthetic valve comprises a mechanical valve.
19. The heart valve assembly of claim 13, wherein the prosthetic valve comprises a bioprosthetic valve.
20. A method for implanting a prosthetic heart valve assembly within a biological annulus below a sinus cavity, comprising:
introducing an annular prosthesis comprising an annular member and a collar into the sinus cavity until the annular member is disposed within the biological annulus and the collar is disposed within the sinus cavity above the annular member;
securing the annular prosthesis relative to the biological annulus with the annular member within the biological annulus;
introducing a valve prosthesis into the sinus cavity towards the annular prosthesis; and
securing the valve prosthesis to the collar.
21. The method of claim 20, wherein the annular prosthesis comprises a sewing ring extending radially outwardly from the annular member, wherein securing the annular prosthesis comprises directing a plurality of fasteners through the sewing ring into tissue adjacent the biological annulus.
22. The method of claim 20, further comprising directing at least a portion of the collar to access the sewing ring before directing the plurality of fasteners through the sewing ring.
23. The method of claim 20, further comprising directing the valve prosthesis towards the collar until a portion of the valve prosthesis is captured by one or more connectors on the collar.
24. The method of claim 23, the one or more connectors on the collar comprising a plurality of detents extending at partially inwardly from the collar for capturing a portion of the valve prosthesis thereunder.
25. The method of claim 24, wherein the plurality of detents comprise tabs, the tabs being deflectable radially outwardly when a frame of the valve prosthesis is directed into the collar, the tabs resiliently biased to return inwardly to capture a portion of the frame thereunder.
26. The method of claim 20, wherein the collar and valve prosthesis comprise substantially circular shapes, the method further comprising rotating the valve prosthesis relative to the collar after securing the valve prosthesis to the collar.
27. The method of claim 20, wherein the collar is directed towards the annular member when the valve prosthesis is secured to the collar, the collar resiliently moving away from the annular member after the valve member is secured to the collar.
28. The method of claim 20, wherein, after the valve member is secured to the collar, the valve member is supported by the collar within the sinus cavity away from other vessels communicating with the sinus cavity.
29. The method of claim 28, wherein the biological annulus comprises a site of an aortic valve, the sinus cavity comprises the sinus of Valsalva, and the other vessels comprise the coronary arteries.
30. The method of claim 20, wherein, after the valve member is secured to the collar, the valve member is supported by the collar within the sinus cavity so as not to obstruct substantially flow of blood into other vessels communicating with the sinus cavity.
Description
    RELATED APPLICATION DATA
  • [0001]
    This application claims benefit of provisional application Ser. No. 60/743,185, filed Jan. 27, 2006, the entire disclosure of which is expressly incorporated herein by reference.
  • FIELD OF THE INVENTION
  • [0002]
    The present invention relates generally to heart valves that may be implanted within a patient, and, more particularly, to multiple component heart valve assemblies, and to apparatus and methods for making and using them.
  • BACKGROUND
  • [0003]
    Prosthetic heart valves can replace defective human valves in patients. For example, one piece valves have been suggested that include sewing rings or suture cuffs that are attached to and extend around the outer circumference of a prosthetic valve. In addition, multiple component valves have also been suggested that include a sewing ring that is separate from a valve component. The sewing rings of either type of prosthetic valve can be tedious and time consuming to secure within a target site, i.e., within an annulus of a heart where a natural heart valve has been removed.
  • [0004]
    For example, to implant a sewing ring within an annulus of a heart, between twelve and twenty sutures may be secured initially to tissue surrounding the annulus. The sewing ring and/or the entire prosthetic valve may then be advanced or “parachuted” down the sutures into the annulus. Knots may then be tied with the sutures to secure the sewing ring within the annulus, whereupon the sutures may be cut. Consequently, this procedure can be very complicated, requiring management and manipulation of many sutures. The complexity of the procedure also provides a greater opportunity for mistakes and requires a patient to be on cardiopulmonary bypass for a lengthy period of time.
  • [0005]
    Because the annulus of the heart may not match the circular cross-section of the sewing ring and/or prosthetic valve, the prosthetic valve may not fit optimally within the annulus. As a result, natural blood hemodynamics through and around the valve may be impaired, resulting in clotting, possible emboli production, and eventual calcification of the valve structure.
  • [0006]
    To address this concern, flexible sewing rings have been suggested for use with multiple component valves. The sewing ring may be implanted within the annulus, e.g., using the procedure described above, i.e., parachuted down an arrangement of sutures. The sewing ring may conform at least partially to the anatomy of the annulus. Alternatively, instead of using sutures, it has also been suggested to drive staples through the sewing ring into the surrounding tissue to secure the sewing ring.
  • [0007]
    When a mechanical or other prosthetic valve is then attached to the sewing ring, however, the valve and sewing ring may not mate together effectively, e.g., if the shape of the sewing ring has been distorted to conform to the annulus, which may also impair natural blood hemodynamics, create leaks, and/or otherwise impair performance of the prosthetic valve.
  • SUMMARY OF THE INVENTION
  • [0008]
    The present invention is directed to heart valves that may be implanted within a patient, and, more particularly, to multiple component heart valve assemblies, and to apparatus and methods for making and using them.
  • [0009]
    In accordance with one embodiment, a prosthesis is provided for receiving a prosthetic valve to replace a preexisting natural or prosthetic heart valve within a biological annulus adjacent a sinus cavity. The prosthesis may include an annular member implantable within the biological annulus, a collar extending upwardly from the annular member, and a sewing ring extending radially outwardly from at least one of the annular member and the collar. The collar and/or annular member may be resiliently compressible, expandable, and/or otherwise movable relative to one another. For example, the collar may be biased to a predetermined orientation, e.g., substantially aligned with a longitudinal axis of the annular member, yet may be compressible axially towards the annular member and/or movable transversely relative to the longitudinal axis.
  • [0010]
    In accordance with another embodiment, a prosthesis is provided for receiving a prosthetic valve to replace a preexisting natural or prosthetic heart valve within a biological annulus adjacent a sinus cavity. The prosthesis may include an annular member implantable within the biological annulus for contacting tissue surrounding the biological annulus, a collar for engaging with a prosthetic valve, and a spring structure for supporting the collar away from the annular member, e.g., along a longitudinal axis. For example, the spring structure may allow the collar to be compressed towards the annular member along the longitudinal axis and/or transversely relative to the longitudinal axis, yet be resiliently biased to a predetermined position away from the annular member. Optionally, the prosthesis may include a sewing ring, e.g., extending radially outwardly from at least one of the collar and the annular member. The spring structure may also allow the collar to be deflected, folded, and/or compressed transversely relative to the longitudinal axis, e.g., to facilitate accessing the sewing ring and/or annular member during implantation.
  • [0011]
    In accordance with still another embodiment, a heart valve assembly is provided for implantation within a biological annulus. The heart valve assembly may include an annular prosthesis that includes an annular member implantable within a biological annulus, a collar extending upwardly from the annular member, and a spring structure for supporting the collar away from the annular member, e.g., along a longitudinal axis of the annular member. The heart valve assembly also includes a prosthetic valve, e.g., a mechanical or bioprosthetic heart valve, which may have a circular or multiple lobular shape for implantation above the biological annulus.
  • [0012]
    Optionally, one or more connectors may be provided on at least one of the collar and the prosthetic valve for securing the prosthetic valve to the annular prosthesis. For example, the one or more connectors may include a plurality of tabs or detents, a drawstring, and the like on the collar for engaging a frame of the prosthetic valve. Alternatively, the one or more connectors may include one or more latches, detents, interlocking elements, e.g., on the prosthetic valve and/or the annular prosthesis.
  • [0013]
    In one embodiment, the collar may include a plurality of tabs that capture a portion of a frame of the prosthetic valve when the prosthetic valve is directed into engagement with the collar. Optionally, the tabs may be movable, e.g., using a tool, to release the prosthetic valve from the collar.
  • [0014]
    In exemplary embodiments, the collar, annular member, spring structure, and/or sewing ring may be formed from resiliently flexible material, e.g., metal, such as Nitinol, Elgiloy, or stainless steel, an elastomer, such as silicone, or other plastic material, and may be covered at least partially with a fabric covering. The collar, annular member, and/or spring structure may be formed as a unitary piece or may be separate components that are attached to one another, e.g., before or after being covered with fabric.
  • [0015]
    In accordance with yet another embodiment, a method is provided for implanting a prosthetic heart valve assembly within a biological annulus, e.g., adjacent a sinus cavity. An annular member may be introduced into the biological annulus, e.g., to direct tissue surrounding the biological annulus outwardly and/or to at least partially dilate the biological annulus. A flexible sewing ring may extend around the annular member that may receive one or more connectors, e.g., sutures, clips, and the like, to secure the annular member relative to the annulus.
  • [0016]
    In one embodiment, a collar or stand-off extends upwardly from the annular member for receiving the prosthetic valve. The collar may be coupled to the annular member by a spring structure, which may bias the collar to a predetermined position relative to the annular member, but allow the collar to be moved relative to the annular member. For example, the collar may be folded or otherwise moved transversely to facilitate access to the sewing ring, e.g., for directing one or more connectors through the sewing ring. In addition, the collar may be compressible towards the annular member, but resiliently biased to direct the collar upwardly, e.g., within the sinus cavity above the biological annulus.
  • [0017]
    A prosthetic valve, e.g., a mechanical or bioprosthetic valve, may be advanced into the sinus cavity, and secured relative to the annular member. For example, the prosthetic valve may be secured to the collar using one or more connectors, e.g., a plurality of tabs or detents on the collar, a drawstring in the collar, one or more sutures, clips, detents, and/or other cooperating connectors, e.g., on the collar and/or frame of the valve prosthesis.
  • [0018]
    The collar may support the prosthetic valve above the tissue biological, e.g., within the sinus cavity, e.g., the sinus of Valsalva above an aortic valve site. In addition or alternatively, the collar may allow the prosthetic valve to have a larger size than the annular member, thereby enhancing the fluid flow or other performance characteristics of the implanted heart valve assembly. Optionally, the collar may include a funnel or other tapered shape that may provide a transition from a relatively larger prosthetic valve to the annular member within the biological annulus. In addition, the collar may support the prosthetic valve away from a wall of the sinus or other supra-annular space, while still allowing blood to flow easily into the coronary arteries around the prosthetic valve.
  • [0019]
    In another option, the prosthetic valve may be removable from the collar, e.g., to allow the prosthetic valve to be replaced. In addition or alternatively, the collar and prosthetic valve may have a substantially circular shape, which may allow the prosthetic valve to be secured to the collar, yet be rotatable relative to the collar.
  • [0020]
    Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • [0021]
    The drawings illustrate exemplary embodiments of the invention, in which:
  • [0022]
    FIG. 1 is a partial cross-sectional side view of an exemplary embodiment of a gasket member with a fabric covering.
  • [0023]
    FIG. 2 is a side view of a collar including a spring structure and an annular ring that may be provided in the gasket member of FIG. 1.
  • [0024]
    FIG. 3A is a cross-sectional side view of an unfinished blank that may be formed into the collar and spring structure of FIG. 2.
  • [0025]
    FIG. 3B is a cross-sectional side view of a collar and spring structure formed from the blank of FIG. 3A.
  • [0026]
    FIG. 4 is a perspective view of a two piece heart valve assembly including a gasket member of FIG. 1 and a mechanical valve.
  • [0027]
    FIG. 5 is a cross-sectional view of an aortic valve site, having the heart valve assembly of FIG. 4 implanted therein.
  • DETAILED DESCRIPTION
  • [0028]
    Turning to the drawings, FIGS. 1-5 show an exemplary embodiment of a heart valve assembly 10 that generally includes a gasket member 12 and a valve member 14. Generally, the gasket member 12 includes an annular ring 18, a sewing ring 20 extending radially from the annular ring 18, and a collar 22 extending upwardly from the annular ring 18. The valve member 14 may be a prosthetic valve, e.g., a mechanical or bioprosthetic valve, that may be secured to the collar 22 and/or other portion of the gasket member 12, e.g., after implanting the gasket member 12 within a tissue annulus, as described further elsewhere herein.
  • [0029]
    Turning to FIGS. 4 and 5, the valve member 14 may be a mechanical valve including an annular frame 32 supporting a pair of valve members 38 (shown in FIG. 5) that open and close within the frame 32. Optionally, the valve member 14 may include a pair of ears 34 extending downwardly from the frame 32, e.g., for pivotally supporting the valve members 38. In an exemplary embodiment, the valve member 14 may be a mechanical valve, such as the “Regent” Bileaflet Valve manufactured by St. Jude Medical. In alternative embodiments, the valve member 14 may be another mechanical or bioprosthetic valve, such as those disclosed in U.S. Pat. No. 6,371,983 or U.S. Publication Nos. 2005/0043760, 2006/0235508, or 2006/0276888, the entire disclosures of which are expressly incorporated by reference herein.
  • [0030]
    Returning to FIGS. 1 and 2, an exemplary embodiment of the gasket member 12 is shown that includes an annular ring 18, a sewing ring 20, a collar 22, and a spring structure 40 supporting the collar 22 relative to the annular ring 18. Fabric 24 may cover all or at least a portion of the gasket member 12, e.g., the annular ring 18, the sewing ring 20, the collar 22, and/or the spring structure 40, for example, to allow tissue ingrowth and/or provide desired flexibility, similar to embodiments described in US Publication Nos. 2004/0122516, 2005/0165479, 2006/0195184, and 2007/0016285, the entire disclosures of which are expressly incorporated by reference herein.
  • [0031]
    In one embodiment, the annular ring 18 may have a generally circular shape, e.g., defining a central longitudinal axis 19. Alternatively, the annular ring 18 may have a multi-lobular shape about its circumference, e.g., including three lobes separated by scallops or cusps (not shown). In addition or alternatively, the annular ring 18 may generally define a plane substantially perpendicular to the axis 19 or may have a sinusoidal or other shape that extends above and below a plane.
  • [0032]
    Optionally, the annular ring 18 may be expandable and/or contractible such that the diameter may be adjusted. In one embodiment, the annular ring 18 may be biased to expand to a predetermined diameter. If desired, the annular ring 18 may be contracted radially to a smaller diameter, e.g., folded or compressed to facilitate delivery into a biological annulus, yet may be resiliently expandable to the predetermined diameter, e.g., to dilate tissue surrounding the biological annulus and/or to facilitate securing the gasket member 12 within the biological annulus.
  • [0033]
    The annular ring 18 may be formed from an elastic or superelastic material, e.g., metal such as Nitinol, Elgiloy, stainless steel, and the like, a polymer or other plastic, and/or a composite material. In an exemplary method, the annular ring 18 may be cut from a flat sheet of base material having a desired thickness for the annular ring 18, e.g., by laser cutting, mechanical cutting, and the like. For example, the annular ring 18 may be initially formed as a long band of material (not shown), having a width corresponding to the desired height “h” of the annular ring 18 and a length corresponding to a circumference (π d) of the desired diameter “d” of the annular ring 18, as shown in FIG. 2. The band may be wrapped around a mandrel or otherwise restrained in a generally cylindrical shape with the ends adjacent to one another, and the band may be heat treated or otherwise processed to program the generally cylindrical shape to create the annular ring 18. The generally cylindrical shape may include the ends overlapping one another, spaced apart from one another to provide an open “C” shape, or attached to one another.
  • [0034]
    Fabric may be wrapped at least partially around the annular ring 18, while accommodating expansion and contraction of the annular ring 18, if the annular ring 18 is expandable. For example, at least near the ends, the fabric may not be secured to the annular ring 18, while sutures and the like (not shown) may secure the fabric to other portions of the annular ring 18. Alternatively, the entire annular ring 18 may be free to slide within a fabric sleeve (not shown) wrapped around the annular ring 18. Additional information on the construction of the annular ring 18 may be found in the references incorporated by reference elsewhere herein.
  • [0035]
    The collar 22 may be spaced apart and/or extend upwardly from the annular ring 18. For example, as best seen in FIGS. 2 and 4, the collar 22 may be coupled to the annular ring 18 by the spring structure 40. Generally, the spring structure 40 may allow the collar 22 to be resiliently compressed or otherwise directed towards the annular ring 18, e.g., substantially along the axis 19. In addition or alternatively, the spring structure 40 may allow the collar 22 to be folded, compressed, or otherwise directed inwardly and/or transversely relative to the axis 19, as described further elsewhere herein.
  • [0036]
    The collar 22 may be a generally circular annular band 22 for receiving or otherwise engaging the valve member 14, e.g., as described further below. In one embodiment, the collar 22 may include a lower rim 22 a defining a lip 17 and a sidewall 22 b extending upwardly from the rim 22 a, thereby defining a recess 23 for receiving the valve member 14 therein. In addition, the collar 22 may include one or more connectors, e.g., a plurality of detents 16, for securing the valve member 14 within the recess 23 and/or otherwise to the collar 22. As shown, the detents 16 include tabs extending downwardly and inwardly from the sidewall 22 b, e.g., defining an angle relative to the axis 19. The tabs 16 may be biased inwardly but may be resiliently deflectable outwardly, e.g., during introduction of the valve member 14. Lower, free ends 16 a of the tabs 16 may be spaced above the lip 17, e.g., for capturing a portion of the valve member 14 between the rim 22 a and the tabs 16, as described further below.
  • [0037]
    In addition or alternatively, the collar 22 and/or other portion of the gasket member 12 may include one or more connectors in addition to or instead of the detents 16. For example, the collar 22 may include a plurality of fasteners, clips, latches, and the like (not shown) inset within or otherwise attached to the collar 22, e.g., similar to those disclosed in US Publication Nos. 2006/0195184 and 2006/0235508, incorporated by reference above. Alternatively, the gasket member 12 may include a plurality of guide rails or other elongate members (not shown) extending from the collar 22 and/or sewing cuff 20 for guiding the valve member 14 towards the gasket member 12 and/or securing the valve member 14 to the gasket member 12, similar to the elongate members disclosed in Publication No. 2005/0165479, incorporated by reference above, or co-pending application Ser. No. 60/746,038, filed Apr. 29, 2006, the entire disclosure of which is expressly incorporated by reference herein.
  • [0038]
    Returning to FIGS. 2-3B, the spring structure 40 may include an annular base 42 and a helically shaped spring member 44 extending upwardly from the base 42, e.g., spiraling around the axis 19. The spring member 44 may be coupled to the collar 22 and the base 42 may be coupled to the annular ring 18. Alternatively, the spring member 44 may be coupled directly to the annular ring 18 and the base 42 may be eliminated (not shown). The spring member 44 may be sufficiently rigid to bias the collar 22 to a predetermined position relative to the annular ring 18. For example, the spring member 44 may bias the collar to align axially above the annular ring 18 along the longitudinal axis 19. In addition or alternatively, the spring member 44 may bias the collar 22 to be spaced a predetermined distance from the annular ring 18, e.g., at a height “x” above the annular ring 18.
  • [0039]
    As shown, in one embodiment, the base 42 and spring member 44 of the spring structure 40 and the collar 22 may be formed as a unitary piece. For example, the collar 33 and/or spring structure 40 may be formed by machining, molding, casting, stamping, etching, and the like. Alternatively, the base 42, spring member 44, and/or collar 22 may be formed as separate pieces that are attached to one another, e.g., by bonding, sonic welding, cooperating connectors, interference fit, and the like (not shown). Similar to the annular ring 18, the spring structure 40 and/or collar 22 may be formed from metal, such as Nitinol, Elgiloy, stainless steel, and the like, a polymer or other plastic, and/or a composite material. For example, in an alternative embodiment, the spring member 44 may be a metal spring, the base 42 may be formed from silicone or other elastomer (e.g., also providing a core for the sewing ring 20 as well as a base for the spring member 44), and the collar 22 may be formed from Nitinol or other metal attached to the spring member 44.
  • [0040]
    Turning to FIGS. 3A and 3B, in an exemplary embodiment, the collar 22 and spring structure 40 may be formed as a unitary piece from a blank using a laser machining process. Turning to FIG. 3A, a blank may be provided for an unfinished collar 22 that generally includes a lower sidewall section A, an upper sidewall section B, and a base section D, all disposed substantially symmetrically around the longitudinal axis 19. The blank may be formed by machining, molding, casting, and the like from desired materials, e.g., Nitinol, stainless steel, Elgiloy, plastic, and the like. Initially, the blank may have generally cylindrical continuous sidewalls having a greater thickness at section A than at section B, thereby defining lip 17 between sections A and B. The base section D may extend inwardly from section B and may include an opening C therethrough aligned with the longitudinal axis 19, e.g., having a diameter corresponding to the size of the annular ring 18, as seen in FIG. 2. Thus, sections A and B may have a relatively large diameter compared to the opening C.
  • [0041]
    Optionally, section D may have a tapered or other shape that may conform at least partially to a shape of a biological annulus into which the resulting annular prosthesis 12 is implanted. In addition or alternatively, section D may include a plurality of openings 28 extending therethrough, e.g., for accommodating sutures, staples or other connectors therethrough. The openings C, 28 may be cut, bored, drilled, or otherwise formed through the base 42 or may be created when the base 42 is molded, cast, and the like.
  • [0042]
    Turning to FIG. 3B, a plurality of tabs 16 may be formed through section A. For example, a plurality of elongate openings 21 may be laser cut (or otherwise created) through section A that extend around the circumference of section A. The remaining material around the openings 21 provides the sidewall 22 b of the collar 22 and define a plurality of tabs 16. Thus, the tabs 16 may be fixed at upper ends 16 b to the sidewall 22 b and may include free lower ends 16 a. As shown in FIG. 4, at least some of the tabs 16 may be bent inwardly from the sidewall 22 b, e.g., by heat-setting the bent shape, bending the tabs 16 beyond their elastic limit, and the like.
  • [0043]
    With continued reference to FIGS. 3A and 3B, portions of Section B may be removed, leaving the rim 22 b of the collar 22 and the spring member 44. As shown, the spring member 44 may have a height similar to the thickness of Section B, e.g., such that the spring member 44 has a substantially square cross-section. It will be appreciated that other cross-sections may be provided having desired mechanical properties, e.g., a desired spring constant.
  • [0044]
    Although described in an exemplary order, it will be appreciated that the sequence of the steps described above for forming the collar 22 and spring structure 40 are merely exemplary. The procedure described may be performed in any order, i.e., such that the collar 22, spring member 44, and/or base 42 may be created sequentially or simultaneously with one another.
  • [0045]
    Optionally, as shown in FIGS. 3A-4, a lower recess 29 may be formed or otherwise provided in the base 42 of the spring structure 40, e.g., around opening C. This recess 29 may be sized to receive an upper edge of the annular ring 18 therein.
  • [0046]
    With additional reference to FIGS. 1 and 4, the sewing ring 20 may be attached to or otherwise extend around the annular ring 18 and/or spring structure 40. For example, the sewing ring 20 may include one or a plurality of layers of fabric or other material extending radially outwardly from the base 42 and/or the annular ring 18. Alternatively, the sewing ring 20 may include flexible core material 25, e.g., silicone or other elastomeric materials, foam, fabric, felt, polymers, and the like, that may be attached to or otherwise extend around the base 42 and/or annular ring 18, as described in the references incorporated by reference elsewhere herein. Such a core 25 may be molded, fused, bonded, and the like to the base 42 and/or annular ring 18 or may simply be disposed around the base 42 and/or annular ring 18 and held in place by an overlying layer of fabric.
  • [0047]
    Generally, to make the annular prosthesis shown in FIG. 1, the annular ring 18 may be formed as described above. Optionally, a lower baleen or skirt 26 may be formed that extends downwardly and/or outwardly from the annular ring 18. The skirt 26 may be formed and/or attached to the annular ring 18 as described in the references incorporated by reference elsewhere herein.
  • [0048]
    The collar 22 and spring structure 40 may be formed as described above, before, after, or in conjunction with the annular ring 18 and/or skirt 26. Once formed, the annular ring 18 may be disposed with the upper edge within the recess 29 within the base 42 of the spring structure 40. Optionally, the annular ring 18 may be attached to the base 42, e.g., by bonding, welding, an interference fit, and the like. Otherwise, the upper edge of the annular ring 18 may simply be placed within the recess 29, and fabric may be wrapped around the annular ring 18 and/or base 42 to hold the annular ring 18 adjacent the base 42. Optionally, one or more sutures (not shown) may be directed through openings (also not shown) in the annular ring 18 and base 42 to secure the annular ring 18 adjacent the base 42.
  • [0049]
    In an alternative embodiment, the base 42 of the spring structure 40 may be eliminated. In this alternative, the lower end of the spring member 44 may be attached directly to the annular ring 18. For example, the lower end of the spring structure 40 may be bonded, fused, or otherwise attached to an upper region of the annular ring 18.
  • [0050]
    If the sewing ring 20 includes a core 25, the core 25 may be attached around the base 42 and/or the annular ring 18. The core material may be bonded, molded, or otherwise attached to the base 42 and/or annular ring 18. Fabric may be wrapped or otherwise secured around the core 25, the annular ring 18, the base 42, the spring member 44, and the collar 22, e.g., using known sewing or other methods. The resulting prosthesis 12 shown in FIG. 1 may be entirely covered with fabric (omitted in part only to show the internal components of the prosthesis 12).
  • [0051]
    As fabric is being secured around the collar 22 and/or spring member 44, the collar 22 may be directed and maintained partially towards the annular ring 18. After securing the fabric, the collar 22 may be released, thereby applying tension on the fabric as the spring member 44 attempts to bias the collar 22 away from the annular member 18. This tension may pull the fabric slightly, e.g., to reduce the risk of the fabric puckering. The fabric may cover the tabs 16 within the collar 22 or openings may be provided in the fabric to allow the tabs to extend therethrough. If the fabric covers the tabs 16, the fabric should not be tensioned to cause the tabs 16 to deflected outwardly from their relaxed position.
  • [0052]
    Thus, turning to FIG. 4, the resulting annular prosthesis 12 may have a relaxed condition, i.e., free from external forces, in which the collar 22 is spaced apart from the annular ring 18 and/or base 42. The collar 22 may have sufficient height “x” relative to the annular ring 18 to accommodate receiving the frame 32 of the valve member 14 without the ears 34 extending down into the annular ring 18. The collar 22 may include one or more grooves (not shown) formed within the collar 22, which may accommodate the ears 34 of the valve member 14. The collar 22 may have sufficient structural integrity to support the valve member 14, yet be sufficiently flexible to be deformable to facilitate introduction into a patient's body and/or to move the collar 22 away to accommodate delivering one or more connectors (not shown) into the sewing ring 20.
  • [0053]
    Turning to FIG. 5, during use, the gasket member 12 may be implanted within a patient's body, e.g., within or adjacent to a biological annulus 90. The biological annulus 90 may be the site for replacement of an existing natural or previously implanted heart valve, such as a tricuspid, mitral, aortic, or pulmonary valve within a patient's heart (not shown). With the annular ring 18 contracted into a relatively small diameter (if the annular ring 18 is radially compressible), the gasket member 12 may be advanced into the annulus using a delivery tool (not shown). Exemplary tools, apparatus, and methods for compressing and/or delivering the gasket member 12 are disclosed in co-pending application Ser. No. 60/746,038, filed Apr. 29, 2006, incorporated by reference above.
  • [0054]
    The gasket member 12 may be advanced until the annular ring 18 extends at least partially into the biological annulus 90. In one embodiment, the annular ring 18 extends entirely through the biological annulus 90, with the lower edge of the annular ring 18 remaining free within the sub-annular space below 92 the biological annulus 90.
  • [0055]
    Optionally, as shown, the gasket member 12 may include a flexible skirt 26 that extends through the annulus. The skirt 26 may be biased to extend outwardly as shown to provide a smooth transition and/or enhance a seal between the heart vale assembly 10 and the biological annulus.
  • [0056]
    The sewing ring 20 may contact the tissue within the supra-annular space 94 above the biological annulus 90, although the sewing ring 20 may not provide any structural support of the annular ring 18. For example, the sewing ring 20 may be substantially flexible, e.g., conforming substantially to the shape of the supra-annular space 94.
  • [0057]
    If the annular ring 18 is expandable or otherwise compressed, the annular ring 18 may then be expanded within the biological annulus 90, e.g., to dilate the biological annulus or otherwise direct the surrounding tissue outwardly against the underlying tissue structures. For example, the annular ring 18 may simply be released by the delivery tool, whereupon the annular ring 18 may resiliently expand against the tissue surrounding the biological annulus 90, thereby substantially securing the annular ring 18 (and consequently, the gasket member 12) relative to the biological annulus 90. In addition or alternatively, a dilation tool (not shown) may be advanced into the gasket member 12 and expanded to forcibly (e.g., plastically) expand the annular ring 18 within the biological annulus 90.
  • [0058]
    If the sewing ring 20 is restrained by the delivery tool, the sewing ring 20 may be released to allow the sewing ring 20 to contact the surrounding tissue, e.g., within the aortic root above the biological annulus 90. Because of the floppy (i.e., flexible and conformable) nature of the core, the sewing ring 20 may adopt the shape of the surrounding tissue, e.g., lying flatter within the coronary sinus regions, while becoming more vertical adjacent the commissures.
  • [0059]
    With the gasket member 12 in place, a plurality of fasteners 96, e.g., clips, staples, sutures, and the like, may be directed through the sewing ring 20 into the tissue surrounding the biological annulus 90 to secure the gasket member 12 relative to the biological annulus 90. In addition or alternatively, a plurality of fasteners (not shown) may be directed through the openings 28 in the base 42 to secure the gasket member 12 relative to the biological annulus 90. Exemplary fasteners and apparatus and methods for delivering them are disclosed in U.S. Publication Nos. 2005/0080454 and 2006/0122634, the entire disclosures of which are expressly incorporated by reference herein.
  • [0060]
    To facilitate accessing the sewing ring 20 during delivery of the fasteners 96, local portions of the collar 22 may be at least partially deflected out of the way. For example, the collar 22 may be folded inwardly to move fabric and other obstructions out of the way, e.g., similar to the embodiments disclosed in U.S. Publication No. 2007/0016285, incorporated by reference herein. Thus, the flexibility of the collar 22 may facilitate visual and/or tactile access to one or more portions of the sewing ring 20, whereupon one or more fasteners 96 may be delivered through the accessed portion(s) of the sewing ring 20. After delivering the fastener(s) 96, the collar 22 may be released, whereupon the collar 22 may resiliently return outwardly to its annular shape.
  • [0061]
    The valve member 14 may then be advanced into the biological annulus 90, e.g. using another delivery tool or the same tool (not shown) used to deliver the gasket member 12. The valve member 14 may then be secured to the collar 22. For example, as shown in FIG. 5, the valve member 14 may be directed into the recess 23 of the collar 22 such that a lower portion 36 of the frame 32 contacts and directs the tabs 16 radially outwardly. Once the lower portion 36 of the frame 32 passes below the free ends 16 a of the tabs 16, the tabs 16 may resiliently return inwardly to capture the lower portion 36 below the free ends 16 a. The inwardly biased tabs 16 thereafter prevent the valve member 14 from moving upwardly, because the lower portion 36 of the frame 32 contacts the tabs 16, thereby securing the valve member 14 to the gasket member 12.
  • [0062]
    In addition or alternatively, the collar 22 and/or valve member 14 may include other connectors (not shown), e.g., a drawstring, sutures, guide rails, and the like to secure the valve member 14 relative to the collar 22. Exemplary connectors are disclosed in the references incorporated elsewhere herein, e.g., in US Publication Nos. 2006/0195184 and 2006/0235508, or in application Ser. No. 60/746,038, incorporated by reference above.
  • [0063]
    Optionally, if the collar 22 and frame 32 are generally circular, it may be possible to rotate the valve member 14 within the collar 22. As the valve member 14 is rotated, the lower portion 36 of the frame 32 may simply slide around under the tabs 16. Thus, the valve member 14 may be rotated to a desired angular orientation within the biological annulus 90.
  • [0064]
    Once the valve member 14 is secured, any tools may be removed, and the procedure completed using known methods.
  • [0065]
    The collar 22 may support the valve member 14 within a sinus cavity 98 above the biological annulus 90. For example, the spacing of the collar 22 from the annular ring 18 may predispose the valve member 14 within the sinus of Valsalva above an aortic valve site. During implantation, if desired, the valve member 14 may be pressed into the collar 22, whereupon the spring structure 40 may deform, allowing the collar 22 to move axially towards the annular ring 18. When the valve member 14 is released within the sinus cavity 98, the spring structure 40 may resiliently move upwardly away from the biological annulus 90. Thus, the spring structure 40 may be radially soft and flexible, while providing desired axial support for the valve member 14.
  • [0066]
    Because the valve member 14 is supported within the sinus cavity 98 in this manner, the valve member 14 may be selected from a larger size than the diameter or other cross-section of the biological annulus 90. For example, it may be possible to select a valve member 14 that is at least about two millimeters (2 mm) larger than the annular ring 18 for aortic valve applications. In addition, the valve member 14 and collar 22 may allow blood to flow around the valve member 14, e.g., to enter the coronary arteries or other vessels (not shown) communicating with the sinus cavity 98. Even though the valve member 14 and collar 22 are larger than the annular ring 18 and biological annulus 90, the sinus cavity 98 may be sufficiently large to allow blood to flow around the valve member 14 and collar 22 into the coronary arteries or other vessels adjacent the biological annulus 90.
  • [0067]
    In addition or alternatively, the sewing ring 20 may have a tri-lobular or other shape (not shown) that may avoid obstructing the coronary arteries or other vessels communicating with the sinus cavity 98. Optionally, the sewing ring 20 may include a stiffening structure, e.g., core 25, to maintain perfusion of the coronary arteries or other vessels communicating with the sinus cavity 98.
  • [0068]
    If desired, the collar 22 may allow the valve member 14 to be removed from the sinus cavity 98, e.g., to be replaced with a new valve. To remove the valve member 14, a tool may be inserted between the frame 32 and the sidewall 22 b, e.g., to deflect the tabs 16 radially outwardly. With the tabs 16 deflected outwardly, the lower portion 36 of the frame 32 may be lifted past the tabs 16, allowing the valve member 14 to be removed from the collar 22. Once the valve member 14 is removed, another valve (not shown) may be introduced and received within the collar 22, as desired.
  • [0069]
    It will be appreciated that elements or components shown with any embodiment herein are exemplary for the specific embodiment and may be used on or in combination with other embodiments disclosed herein.
  • [0070]
    While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents and alternatives falling within the scope of the appended claims.
Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US4680031 *Oct 24, 1984Jul 14, 1987Tascon Medical Technology CorporationHeart valve prosthesis
US4892541 *Jan 29, 1987Jan 9, 1990Tascon Medical Technology CorporationHeart valve prosthesis
US5032128 *Jul 7, 1988Jul 16, 1991Medtronic, Inc.Heart valve prosthesis
US5891160 *Dec 4, 1997Apr 6, 1999Cardiovascular Technologies, LlcFastener delivery and deployment mechanism and method for placing the fastener in minimally invasive surgery
US5972004 *Feb 20, 1998Oct 26, 1999Cardiovascular Technologies, Llc.Wire fasteners for use in minimally invasive surgery and apparatus and methods for handling those fasteners
US6042607 *Feb 21, 1997Mar 28, 2000Cardiovascular Technologies LlcMeans and method of replacing a heart valve in a minimally invasive manner
US6371983 *Oct 3, 2000Apr 16, 2002Ernest LaneBioprosthetic heart valve
US6733525 *Mar 23, 2001May 11, 2004Edwards Lifesciences CorporationRolled minimally-invasive heart valves and methods of use
US6939365 *Mar 3, 2003Sep 6, 2005Arbor Surgical Technologies, Inc.Fixturing assembly
US6974476 *May 5, 2003Dec 13, 2005Rex Medical, L.P.Percutaneous aortic valve
US7172625 *Jul 16, 2002Feb 6, 2007Medtronic, Inc.Suturing rings for implantable heart valve prostheses
US7445632 *Sep 9, 2005Nov 4, 2008Rex Medical, L.PPercutaneous aortic valve
US7513909 *Apr 10, 2006Apr 7, 2009Arbor Surgical Technologies, Inc.Two-piece prosthetic valves with snap-in connection and methods for use
US7524330 *Apr 13, 2004Apr 28, 2009Eric BerreklouwFixing device, in particular for fixing to vascular wall tissue
US7556647 *Oct 8, 2003Jul 7, 2009Arbor Surgical Technologies, Inc.Attachment device and methods of using the same
US7575594 *Dec 30, 2005Aug 18, 2009Sieracki Jeffrey MShock dampening biocompatible valve
US7578843 *Apr 1, 2003Aug 25, 2009Medtronic, Inc.Heart valve prosthesis
US7597711 *Jan 26, 2004Oct 6, 2009Arbor Surgical Technologies, Inc.Heart valve assembly with slidable coupling connections
US20010044656 *May 6, 1999Nov 22, 2001Warren P. WilliamsonMeans and method of replacing a heart valve in a minimally invasive manner
US20040044406 *Apr 16, 2003Mar 4, 2004Woolfson Steven B.Fixation band for affixing a prosthetic heart valve to tissue
US20040167620 *Feb 26, 2004Aug 26, 2004MedtentiaAnnuloplasty devices and related heart valve repair methods
US20040210305 *Mar 3, 2004Oct 21, 2004Medtronic, Inc.Suture locking assembly and method of use
US20060009841 *Sep 9, 2005Jan 12, 2006Rex MedicalPercutaneous aortic valve
US20060149367 *Dec 30, 2005Jul 6, 2006Sieracki Jeffrey MShock dampening biocompatible valve
US20060195184 *Feb 28, 2005Aug 31, 2006Ernest LaneConformable prosthesis for implanting two-piece heart valves and methods for using them
US20060195185 *Feb 28, 2005Aug 31, 2006Ernest LaneTwo piece heart valves including multiple lobe valves and methods for implanting them
US20060195186 *Feb 28, 2005Aug 31, 2006Drews Michael JConnectors for two piece heart valves and methods for implanting such heart valves
US20060259135 *Apr 20, 2006Nov 16, 2006The Cleveland Clinic FoundationApparatus and method for replacing a cardiac valve
US20060271175 *Jun 29, 2006Nov 30, 2006Woolfson Steven BFixation band for affixing a prosthetic heart valve to tissue
US20070016285 *May 26, 2006Jan 18, 2007Ernest LaneGasket with Collar for Prosthetic Heart Valves and Methods for Using Them
US20070016288 *Jul 13, 2006Jan 18, 2007Gurskis Donnell WTwo-piece percutaneous prosthetic heart valves and methods for making and using them
US20070150053 *Dec 7, 2006Jun 28, 2007Gurskis Donnell WConnection Systems for Two Piece Prosthetic Heart Valve Assemblies and Methods for Using Them
US20070225801 *Mar 12, 2007Sep 27, 2007Drews Michael JValve introducers and methods for making and using them
US20070260305 *Apr 30, 2007Nov 8, 2007Drews Michael JGuide shields for multiple component prosthetic heart valve assemblies and apparatus and methods for using them
US20070265701 *Apr 30, 2007Nov 15, 2007Gurskis Donnell WMultiple component prosthetic heart valve assemblies and apparatus for delivering them
US20070288089 *Apr 30, 2007Dec 13, 2007Gurskis Donnell WMultiple component prosthetic heart valve assemblies and methods for delivering them
US20080033543 *Apr 30, 2007Feb 7, 2008Gurskis Donnell WFoldable prostheses, multiple component prosthetic heart valve assemblies, and apparatus and methods for delivering them
US20080071361 *Mar 23, 2007Mar 20, 2008Yosi TuvalLeaflet-sensitive valve fixation member
US20080071369 *Mar 23, 2007Mar 20, 2008Yosi TuvalValve fixation member having engagement arms
US20080097595 *Aug 22, 2006Apr 24, 2008Shlomo GabbayIntraventricular cardiac prosthesis
US20080119875 *Jan 30, 2008May 22, 2008Arbor Surgical Technologies, Inc.Apparatus and method for delivering fasteners during valve replacement
US20080281411 *Mar 29, 2005Nov 13, 2008Eric BerreklouwAssembly Comprising A Ring For Attachment In A Passage Surrounded By Body Tissue As Well As An Applicator For Fitting The Ring In The Passage
US20090036903 *May 5, 2008Feb 5, 2009Arbor Surgical Technologies, Inc.Apparatus and methods for delivering fasteners during valve replacement
US20090054974 *Oct 22, 2008Feb 26, 2009Rex MedicalPercutaneous aortic valve
US20090177266 *Mar 5, 2009Jul 9, 2009Powell Ferolyn TMethods, systems and devices for cardiac valve repair
US20090210052 *Jun 20, 2007Aug 20, 2009Forster David CProsthetic heart valves, support structures and systems and methods for implanting same
US20090319038 *Jun 3, 2009Dec 24, 2009Arbor Surgical Technologies, Inc.Connection systems for two piece prosthetic heart valve assemblies and methods for making and using them
US20100030244 *Oct 1, 2009Feb 4, 2010Woolfson Steven BFixation band for affixing a prosthetic heart valve to tissue
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US7708775May 24, 2006May 4, 2010Edwards Lifesciences CorporationMethods for rapid deployment of prosthetic heart valves
US7819915Dec 19, 2003Oct 26, 2010Edwards Lifesciences CorporationHeart valve holders and handling clips therefor
US7887583 *Apr 12, 2005Feb 15, 2011Mvrx, Inc.Heart valve annulus device and method of using same
US7951197Apr 6, 2009May 31, 2011Medtronic, Inc.Two-piece prosthetic valves with snap-in connection and methods for use
US7959674Mar 3, 2004Jun 14, 2011Medtronic, Inc.Suture locking assembly and method of use
US7967857Jan 29, 2007Jun 28, 2011Medtronic, Inc.Gasket with spring collar for prosthetic heart valves and methods for making and using them
US7972377Aug 29, 2008Jul 5, 2011Medtronic, Inc.Bioprosthetic heart valve
US7981153Mar 14, 2005Jul 19, 2011Medtronic, Inc.Biologically implantable prosthesis methods of using
US8021161May 1, 2006Sep 20, 2011Edwards Lifesciences CorporationSimulated heart valve root for training and testing
US8021421Aug 22, 2003Sep 20, 2011Medtronic, Inc.Prosthesis heart valve fixturing device
US8025695Jan 31, 2003Sep 27, 2011Medtronic, Inc.Biologically implantable heart valve system
US8211169May 26, 2006Jul 3, 2012Medtronic, Inc.Gasket with collar for prosthetic heart valves and methods for using them
US8308798Dec 10, 2009Nov 13, 2012Edwards Lifesciences CorporationQuick-connect prosthetic heart valve and methods
US8348998Jun 23, 2010Jan 8, 2013Edwards Lifesciences CorporationUnitary quick connect prosthetic heart valve and deployment system and methods
US8349003Apr 12, 2011Jan 8, 2013Medtronic, Inc.Suture locking assembly and method of use
US8449625Oct 27, 2009May 28, 2013Edwards Lifesciences CorporationMethods of measuring heart valve annuluses for valve replacement
US8460373Jul 1, 2011Jun 11, 2013Medtronic, Inc.Method for implanting a heart valve within an annulus of a patient
US8500798May 24, 2006Aug 6, 2013Edwards Lifesciences CorporationRapid deployment prosthetic heart valve
US8500802Mar 8, 2011Aug 6, 2013Medtronic, Inc.Two-piece prosthetic valves with snap-in connection and methods for use
US8506625Aug 9, 2010Aug 13, 2013Edwards Lifesciences CorporationContoured sewing ring for a prosthetic mitral heart valve
US8551162Dec 20, 2002Oct 8, 2013Medtronic, Inc.Biologically implantable prosthesis
US8574257Aug 10, 2009Nov 5, 2013Edwards Lifesciences CorporationSystem, device, and method for providing access in a cardiovascular environment
US8603161Jul 6, 2009Dec 10, 2013Medtronic, Inc.Attachment device and methods of using the same
US8623080Sep 22, 2011Jan 7, 2014Medtronic, Inc.Biologically implantable prosthesis and methods of using the same
US8641757Jun 23, 2011Feb 4, 2014Edwards Lifesciences CorporationSystems for rapidly deploying surgical heart valves
US8696742Oct 10, 2012Apr 15, 2014Edwards Lifesciences CorporationUnitary quick-connect prosthetic heart valve deployment methods
US8747463Aug 3, 2011Jun 10, 2014Medtronic, Inc.Methods of using a prosthesis fixturing device
US8821569Apr 30, 2007Sep 2, 2014Medtronic, Inc.Multiple component prosthetic heart valve assemblies and methods for delivering them
US8845720Sep 20, 2011Sep 30, 2014Edwards Lifesciences CorporationProsthetic heart valve frame with flexible commissures
US8911493Jul 30, 2013Dec 16, 2014Edwards Lifesciences CorporationRapid deployment prosthetic heart valves
US8986374May 10, 2011Mar 24, 2015Edwards Lifesciences CorporationProsthetic heart valve
US9005277Dec 21, 2012Apr 14, 2015Edwards Lifesciences CorporationUnitary quick-connect prosthetic heart valve deployment system
US9005278Oct 25, 2012Apr 14, 2015Edwards Lifesciences CorporationQuick-connect prosthetic heart valve
US9078747Nov 13, 2012Jul 14, 2015Edwards Lifesciences CorporationAnchoring device for replacing or repairing a heart valve
US9138314 *Feb 10, 2014Sep 22, 2015Sorin Group Italia S.R.L.Prosthetic vascular conduit and assembly method
US9155617Apr 18, 2014Oct 13, 2015Edwards Lifesciences CorporationProsthetic mitral valve
US9248016Mar 3, 2010Feb 2, 2016Edwards Lifesciences CorporationProsthetic heart valve system
US9314334Nov 25, 2013Apr 19, 2016Edwards Lifesciences CorporationConformal expansion of prosthetic devices to anatomical shapes
US9333078Nov 22, 2013May 10, 2016Medtronic, Inc.Heart valve assemblies
US9370418Mar 12, 2013Jun 21, 2016Edwards Lifesciences CorporationRapidly deployable surgical heart valves
US9439762Jan 23, 2013Sep 13, 2016Edwards Lifesciences CorporationMethods of implant of a heart valve with a convertible sewing ring
US9468527Jun 12, 2014Oct 18, 2016Edwards Lifesciences CorporationCardiac implant with integrated suture fasteners
US20050216079 *Apr 12, 2005Sep 29, 2005Ample Medical, Inc.Heart valve annulus device and method of using same
US20140188217 *Feb 10, 2014Jul 3, 2014Sorin Group Italia S.r.I.Prosthetic vascular conduit and assembly method
CN103957842A *Nov 9, 2012Jul 30, 2014梅德坦提亚国际有限公司Device and method for improving fixation of a medical device
EP2591755A1 *Nov 12, 2011May 15, 2013Medtentia International Ltd OyDevice and method for improving fixation of a medical device
WO2013068542A1 *Nov 9, 2012May 16, 2013Medtentia International Ltd OyDevice and method for improving fixation of a medical device
Classifications
U.S. Classification623/2.38, 623/2.4
International ClassificationA61F2/24
Cooperative ClassificationA61F2250/006, A61F2/2409
European ClassificationA61F2/24C
Legal Events
DateCodeEventDescription
Apr 9, 2007ASAssignment
Owner name: ARBOR SURGICAL TECHNOLOGIES, INC., CALIFORNIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:LANE, ERNEST;REEL/FRAME:019136/0780
Effective date: 20070401
Feb 12, 2010ASAssignment
Owner name: MEDTRONIC, INC.,MINNESOTA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:ARBOR SURGICAL TECHNOLOGIES, INC.;REEL/FRAME:023928/0383
Effective date: 20100205
Owner name: MEDTRONIC, INC., MINNESOTA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:ARBOR SURGICAL TECHNOLOGIES, INC.;REEL/FRAME:023928/0383
Effective date: 20100205
Dec 29, 2014FPAYFee payment
Year of fee payment: 4